News & Analysis as of

Exports Generic Drugs

Smart & Biggar

Updates to Health Canada’s regulatory initiatives for 2022-2024, and amendments to Food and Drug Regulations (Exports and...

Smart & Biggar on

Update: Health Canada’s “ Forward Regulatory Plan: 2023-2025” no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug...more

Kramer Levin Naftalis & Frankel LLP

USMCA: Implications for Biologics and Innovation

On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more

Hogan Lovells

EU SPC Manufacturing Waiver Now in Force

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The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469).  The Waiver has been introduced with the stated aim of putting EU generic and...more

Jones Day

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

Jones Day on

The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

Hogan Lovells

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

Hogan Lovells on

On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

Smart & Biggar

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

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The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Holland & Knight LLP

Boletín Mensual de Comercio Internacional: Enero - Información con Énfasis en la Regulación Comercial y de Arbitraje Internacional

Holland & Knight LLP on

Durante el mes de Enero destacan los siguientes temas: Acceso, Compras, Propiedad Intelectual, Comercio, Inversión, Solución de Diferencias, Competencia, Subvenciones, Arbitraje Inversión....more

Goodwin

EU Parliament Takes Steps to Increase Manufacture and Export of European Generics and Biosimilars During Protected Period

Goodwin on

The Committee on Internal Market and Consumer Protection of the European Parliament has adopted its report on the “Single Market Strategy” – a strategy that aims to consolidate industries in European countries under one...more

King & Spalding

In the Wake of Trade Agenda Momentum, TPP Negotiations Continue

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The United States made significant headway with the Administration's trade agenda in the summer of 2015. With the passage of Trade Promotion Authority, Congress has agreed to ensure trade agreements negotiated by the...more

McDonnell Boehnen Hulbert & Berghoff LLP

How the Kirtsaeng Decision Could Ruin the U.S. Branded Drug Industry

The Constitution gives Congress the power to grant copyright and patent protection in the same part of Article I, specifically in Section 8, Clause 8...more

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